MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 4MM X 7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100407
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was reported via the sterling study, a 52-year-old female patient with a history of hypothyroidism underwent coil embolization of a ruptured left middle cerebral artery (mca) side wall aneurysm on 15-dec-2022.The hunt & hess grade was 3, the modified rankin scale (mrs) score was 0.The dimensions of the target aneurysm was as follows: height 4.1mm, dome 5.1mm, maximum aneurysm diameter 5.6mm, neck size 2.2mm, and dome-to-neck ratio of 2.3mm.The parent vessel diameter was 1.7mm.Coil embolization was performed using three (3) cerenovus coils: a 4mm x 7.5cm micrusframe 10 (mfr100407 / 30686615), a 3mm x 4cm galaxy g3 xsft (glx120304 / 30483248), and a 2mm x 2cm galaxy g3 xsft (glx120202 / 30583817) via an sl-10® microcatheter (stryker).In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site.Angiosuite packing density was not mentioned.Immediate post-procedure modified raymond-roy classification score was class i: complete = complete obliteration.There were no reported study device deficiencies or intraoperative complications during the index procedure.On 05-jan-2023, the patient was discharged to home ¿ self-care with an mrs score of 1.On (b)(6) 2023 the patient had an unscheduled visit where imaging was performed.Magnetic resonance angiography (mra) performed on (b)(6) 2023 showed evidence of residual aneurysm.Per the angiographic assessment, the modified raymond-roy classification for the target aneurysm was class iiib: residual aneurysm with contrast along the aneurysm wall.On (b)(6) 2023 , a recurrence of the index aneurysm was detected.Digital subtraction angiography (dsa) on (b)(6) 2023 showed coil compaction and recurrence of aneurysm.The principal investigator assessed this event as severe in severity, serious, probably related to the study device, and unexpected / unanticipated.On (b)(6) 2023 the patient subsequently underwent aneurysm retreatment due to an increase in the size of the aneurysm and coil compacting.The following seven (7) cerenovus coils were used to treat the target aneurysm and a complete obliteration was obtained: 9mm x 15.3cm micrusframe18 (mfr180915 / 30478898); 8mm x 15cm galaxy g3 (gly120815 / 30742431); 7mm x 15cm galaxy g3 (gly120715 / 30677942); 6mm x 15cm galaxy g3 (gly120615 / 30677942); 4mm x 8cm galaxy g3 xsft (glx120408 / 30856198); 3.5mm x 5cm galaxy g3 xsft (glx123505 / 30397843); 2.50mm x 3.50cm galaxy g3 mini (glm925035 / 30780692); the modified raymond-roy classification for the target aneurysm following retreatment was class i: complete = complete obliteration.The patient did not experience any intra-operative aneurysm rupture or thromboembolic event.The patient was discharged to home ¿ self-care (from the retreatment procedure) on (b)(6) 2023.On (b)(6) 2023, modified additional information was received.The information indicated that all original coils remained within the aneurysm sac.There was no herniation.Related to the percentage of aneurysm occlusion when the recanalization was diagnosed, the response received was as follows: ¿since there was regrowth of the original aneurysm in addition to coil prolapse, only 50% of the aneurysm was protected.¿ the patient was not symptomatic as a result of the recanalization.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.Procode is krd/hcg.The initial reporter phone and email address are not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30686615) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Aneurysm recanalization is a known potential adverse event associated with coil embolization procedures.Coil compaction is the decrease in interspaces between the loops of the coils, which leads to smaller coil mesh.It occurs over time after coil placement.Since the alleged coil compaction with aneurysm recanalization necessitated endovascular retreatment to preclude patient complications, the event meets reporting criteria under 21 cfr 803 as a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00225, 3008114965-2023-00226, and 3008114965-2023-00227.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the additional / modified information received from the study site on 07-jul-2023.[additional information]: on 07-jul-2023, modified information was received.The modified information is summarized as follows: on (b)(6) 2023, the patient experienced a recurrence of the index aneurysm.The principal investigator (pi) assessed this event as severe in severity, serious, and probably related to the device.A magnetic resonance angiography (mra) was performed on (b)(6) 2023 and digital subtraction angiography (dsa) was performed on (b)(6) 2023.This event was treated with re-coiling.The event was resolved on (b)(6) 2023 and the patient recovered.Per the information entered in the device deficiency log in the crf, the ¿patient had index procedure for l mca aneurysm on (b)(6) 2022.Mra on (b)(6) 2023 showed evidence of residual aneurysm.Dsa on (b)(6) 2023 showed coil compaction and recurrence of aneurysm.¿ the awareness date for adverse event (acute ischemic stroke in left mca territory) was updated from "31 may 2023" to "25 may 2023.¿ the awareness date for adverse event (recurrence of index aneurysm) was updated from ¿23 mar 2023" to "01 mar 2023.¿ the awareness date for adverse event (recurrence of index aneurysm and coil compaction was updated from "31 may 2023" to "09 may 2023." this is one of 11 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00225, 3008114965-2023-00226, 3008114965-2023-00227, 3008114965-2023-00353, 3008114965-2023-00364, 3008114965-2023-00365, 3008114965-2023-00366, 3008114965-2023-00367, 3008114965-2023-00368, 3008114965-2023-00369, and 3008114965-2023-00354.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 31-may-2023 and modified / additional information received on 08-jun-2023.This report also includes a correction of a lot number of one of the coils that was reported in the initial medwatch report.[additional information]: on 31-may-2023, additional modified information was received.The information indicated that on (b)(6) 2023, the patient experienced a recurrence of the index aneurysm and compaction of the coils previously implanted on (b)(6) 2023.A magnetic resonance angiography (mra) was performed on the same day, which showed a residual aneurysm with modified raymond-roy classification of class iiib: residual aneurysm with contrast along the aneurysm wall.The principal investigator (pi) assessed this event as severe in severity, serious, and causally related to the device.The patient subsequently underwent aneurysm retreatment on (b)(6) 2023 due to an increase in the size of the aneurysm and compaction of the coils previously implanted on (b)(6) 2023.One (1) cerenovus coil, a 6mm x 12.2cm micrusframe 18 (mfr180612 / 30393983) and five (5) non-cerenovus coils were implanted.In addition to the coils, a surpass flow diverter (stryker) was also implanted.Modified raymond-roy classification for the target aneurysm following retreatment was class i: complete = complete obliteration.The patient did not experience an intraoperative aneurysm rupture or any thromboembolic events.The patient outcome was reported as recovered / resolved with sequelae on (b)(6) 2023.The patient also experienced an acute ischemic stroke in the left middle cerebral artery (mca) territory on (b)(6) 2023.The pi assessed this event as event as severe in severity, serious, and probably related to the device.A head & neck computed tomography (ct) angiography, non-contrast ct of the head, and digital subtraction angiography (dsa) were performed.The event was treated with additional stenting (brand not specified) since the surpass flow diverter (stryker) collapsed.The patient outcome was reported as recovering / resolving.Based on the additional modified information received on 31-may-2023, the seven (7) coils used for the retreatment on (b)(6) 2023 due to an increase in the size of the aneurysm and coil compacting, also became compacted and the compaction of the seven coils required another retreatment on (b)(6) 2023.One (1) 6mm x 12.2cm micrusframe 18 (mfr180612 / 30393983) was used as one of the coils for the retreatment.All eight (8) coils have been determined to be us fda reportable under 21 cfr 803 with a classification of ¿serious injury.¿ modified information was received on 08-jun-2023.The modified information contains the following updates: the in-patient or prolonged hospitalization value "no" was updated to "yes." the admission date value was updated to ¿(b)(6) 2023.¿ the discharge date value was updated to ¿(b)(6) 2023.¿ aneurysm recanalization is a known potential adverse event associated with coil embolization procedures.Coil compaction is the decrease in interspaces between the loops of the coils, which leads to smaller coil mesh.It occurs over time after coil placement.Per additional modified information received on 31-may-2023, the patient underwent aneurysm retreatment due to an increase in the size of the aneurysm and compaction of the coils previously placed on (b)(6) 2023.Since the alleged coil compaction with aneurysm recanalization necessitated endovascular retreatment to preclude patient complications, the event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury¿ and an awareness date of 31-may-2023.Updated sections: b.4, g.3, g.6, h.2, h.10, and h.11.This is one of 11 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00226, 3008114965-2023-00227, 3008114965-2023-00353, 3008114965-2023-00364, 3008114965-2023-00365, 3008114965-2023-00366, 3008114965-2023-00367, 3008114965-2023-00368, 3008114965-2023-00369, and 3008114965-2023-00354.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.[correction]: on 09-mar-2023, the patient subsequently underwent aneurysm retreatment due to an increase in the size of the aneurysm and coil compacting.The following seven (7) cerenovus coils were used to treat the target aneurysm and a complete obliteration was obtained: 1) 9mm x 15.3cm micrusframe18 (mfr180915 / 30478898), 2) 8mm x 15cm galaxy g3 (gly120815 / 30742431), 3) 7mm x 15cm galaxy g3 (gly120715 / 30677942), 4) 6mm x 15cm galaxy g3 (gly120615 / 30386788), 5) 4mm x 8cm galaxy g3 xsft (glx120408 / 30856198), 6) 3.5mm x 5cm galaxy g3 xsft (glx123505 / 30397843), 7) 2.50mm x 3.50cm galaxy g3 mini (glm925035 / 30780692).The lot number of the coil listed in #4 was incorrectly reported as 30677942.The correct lot is 30386788.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the additional / modified information received from the study site on 09-oct-2023.[additional information]: on 09-oct-2023, modified information was received.Related to the adverse event ¿recurrence of index aneurysm¿: the field, ¿if event is both serious and device related, in the opinion of the investigator and in accordance with the list of expected events in the protocol, and instructions for use, is the adverse event:¿ was updated from "unexpected / unanticipated" to "expected / anticipated." related to the adverse event ¿recurrence of index aneurysm and coil compaction¿: the field, ¿if event is both serious and device related, in the opinion of the investigator and in accordance with the list of expected events in the protocol, and instructions for use, is the adverse event:¿ was updated from "unexpected / unanticipated" to "expected / anticipated." related to the adverse event ¿acute ischemic stroke in left mca territory¿: the field, ¿if event is both serious and device related, in the opinion of the investigator and in accordance with the list of expected events in the protocol, and instructions for use, is the adverse event:¿ was updated from "unexpected / unanticipated" to "expected / anticipated." updated sections: b.4, g.3, g.6, h.2, and h.10.This is one of 11 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00225, 3008114965-2023-00226, 3008114965-2023-00227, 3008114965-2023-00353, 3008114965-2023-00364, 3008114965-2023-00365, 3008114965-2023-00366, 3008114965-2023-00367, 3008114965-2023-00368, 3008114965-2023-00369, and 3008114965-2023-00354.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the additional / modified information received from the study site on 19-dec-2023.[modified information]: per the modified information received on 19-dec-2023, the outcome value of adverse event ¿acute ischemic stroke in left mca territory¿ has been updated from "recovering / resolving" to "recovered/resolved with sequelae." the end date value has been changed from blank to "05 jun 2023." this is one of 11 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00226, 3008114965-2023-00227, 3008114965-2023-00353, 3008114965-2023-00364, 3008114965-2023-00365, 3008114965-2023-00366, 3008114965-2023-00367, 3008114965-2023-00368, 3008114965-2023-00369, and 3008114965-2023-00354.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report the additional / modified information received from the study site on 19-aug-2024.[modified information]: modified information was received on 19-aug-2024.The modified information is related to the update of the discharge date for adverse events ¿recurrence of index aneurysm and coil compaction¿ and ¿acute ischemic stroke in left mca territory¿ ¿ the discharge date value for both events were updated from "07 jun 2023" to "05 jun 2023." updated sections.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: MICRUSFRAME10 4MM X 7.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16704324
• Report Number: 3008114965-2023-00225
• Device Sequence Number: 5603650
• Product Code: KRD
• UDI-Device Identifier: 10886704077824
• UDI-Public: (01)10886704077824(11)211118(17)241031(10)30686615
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: MFR100407
• Device Catalogue Number: MFR100407
• Device Lot Number: 30686615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 07/07/2023; 10/09/2023; 12/19/2023; 08/19/2024
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/08/2023; 07/10/2023; 10/09/2023; 12/21/2023; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GALAXY G3 XSFT 2MM X 2CM; GALAXY G3 XSFT 3MM X 4CM; SL-10® MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian